Emprint CA30L1 (UDI 10884521806535)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521806535), received between Jul 9, 2021 and Sep 20, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2021Device Alarm System; Leak/Splash; No Flow; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Leak/Splash; No Flow; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE IRRIGATION TUBE ATTACHED TO THE ANTENNA STARTED TO LEAK AT THE MOMENT THEY STARTED THE PUMP SO THE ANTENNA COULD NOT BE COOLED CORRECTLY AND GENERATOR SHOWS THE ALERT OF OVERHEAT. TWO DAYS BEFORE THE ISSUE, A NEW ANTENNA WAS USED WITH THE SAME GENERATOR AND PUMP AND WORKED CORRECTLY. THE PROCEDURE WAS POSTPONED AND RE SCHEDULED TWO DAYS LATER AND THE PATIENT WAS ALREADY SEDATED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12495655 ↗
• MalfunctionJul 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A KIDNEY ABLATION PROCEDURE, THE ANTENNA BROKE OFF WHEN THE DOCTOR TOOK IT OUT OF THE PATIENT. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147845 ↗